eligibility_summary
Inclusion: Ph− B/T-ALL with >10% blasts, completed and recovered from Hyper-CVAD 1A, consent/adherence, ECOG 0–1, EF ≥50%, bilirubin/creatinine <1.5×ULN, AST/ALT <3×ULN, negative pregnancy test, strict contraception (women through 3 mo, men through 30 d, no sperm donation). Exclusion: non–Hyper-CVAD induction, Burkitt L3, active CNS leukemia, recent surgery/radiation, Down syndrome, active infection (HIV/HBV/HCV), serious comorbidity, recent thrombosis, <6 mo life expectancy, active second cancer, pregnant/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1b single-arm study in newly diagnosed Ph− B- or T-ALL testing Hyper-CVAD plus calaspargase pegol (Asparlas, pegylated L-asparaginase enzyme) with rituximab for CD20+ disease. Calaspargase pegol hydrolyzes circulating asparagine (±glutamine), depleting an amino acid essential to ALL blasts with low asparagine synthetase, blocking protein synthesis and inducing apoptosis. Hyper-CVAD targets DNA synthesis/repair and mitosis: cyclophosphamide (alkylator, DNA crosslinks), doxorubicin (anthracycline, topoisomerase II/ROS), vincristine (vinca, microtubule inhibitor), dexamethasone (glucocorticoid-mediated lympholysis), methotrexate (DHFR inhibitor), cytarabine (antimetabolite, DNA polymerase inhibitor). Rituximab (anti-CD20 monoclonal antibody) depletes CD20+ B-cell blasts via CDC/ADCC. Targets: leukemic lymphoblasts, asparagine metabolism, folate/DNA synthesis, microtubules, topoisomerase II, glucocorticoid pathway, CD20.